FALLS CHURCH, Va., Feb. 22 - CSC (NYSE: CSC) announced today that DynPort Vaccine Company LLC (DVC), a CSC company, completed the vaccination and follow-up of all volunteers in a double-blind, placebo-controlled Phase 2 clinical trial for its botulinum vaccine. The trial evaluates safety and immunogenicity of a recombinant botulinum neurotoxin vaccine, rBV A/B, in 440 healthy volunteers 18- to 55-years-old.
The Phase 2 clinical trial aimed to assess the safety of the vaccine against the placebo. These were given to volunteers at two different dosing schedules, with an observation period of seven months. The primary immunogenicity objective was to evaluate the neutralizing antibody rate in volunteers given rBV A/B or placebo. This evaluation period used two different three-dose dosing schedules given at days zero, 28 and 182 or days zero, 56 and 182. These dosing schedules had an 18 months observation period, during which time botulinum neurotoxin antibody levels were measured at established intervals.
The vaccine candidate is being developed to prevent fatal botulism following exposure to aerosolized botulinum neurotoxin serotype A, subtype A1 and serotype B, subtype B1.
"DVC plans to pursue licensure of this vaccine candidate under the U.S. Food and Drug Administration Animal Rule to support our client's medical countermeasure development program," said Dr. Robert V. House, president of DVC. "Botulinum neurotoxin is a key potential biothreat to our nation and its allies."
Two Phase 1 clinical trials, which are complete, evaluated the vaccine in 124 healthy volunteers. Safety and immunogenicity data supported further clinical evaluation of the vaccine candidate in the Phase 2 clinical trial. Clinical trials are managed by DVC at its headquarters in Frederick, Md., and conducted using the services of various clinical research organizations.
In addition to clinical trials, nonclinical testing required to support licensure of rBV A/B under the FDA Animal Rule is ongoing.
Scientists working at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) originally identified and developed the vaccine. DVC further developed and manufactured the vaccine under a U.S.
Department of Defense (DoD) Chemical Biological Medical Systems-Joint Vaccine Acquisition Program (CBMS-JVAP) contract. DVC has served as prime systems contractor for CBMS-JVAP since 1997.
The safety and efficacy of this product in humans has not been established. The product is currently under clinical investigation and has not been licensed by the FDA.
This study was funded by CBMS-JVAP, DoD Contract DAMD17-98-C-8024 and does not represent official DoD positions, policies or decisions.
DynPort Vaccine Company LLC (DVC) manages product development programs and provides consulting, technical and program management services to U.S.
government agencies and companies in the biotechnology and pharmaceutical industries. DVC is part of CSC's North American Public Sector's Civil and Health Services Group. CSC integrates extensive government health services expertise and commercial best practices to meet federal, state and local healthcare requirements. Services range from optimizing claims processing, to operating disease surveillance systems, to biopharmaceutical product development and management. CSC is improving the quality of health care with better information for better decisions. For more information, visit www.csc.com/dvc.
CSC is a global leader in providing technology-enabled solutions and services through three primary lines of business. These include Business Solutions and Services, the Managed Services Sector and the North American Public Sector. CSC's advanced capabilities include system design and integration, information technology and business process outsourcing, applications software development, Web and application hosting, mission support and management consulting. The company has been recognized as a leader in the industry, including being named by FORTUNE Magazine as one of the World's Most Admired Companies for Information Technology Services (2010). Headquartered in Falls Church, Va., CSC has approximately 93,000 employees and reported revenue of $16.2 billion for the 12 months ended December 31, 2010. For more information, visit the company's website at www.csc.com